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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02710-39 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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Gambling disorder (GD) is recognized as an addictive disorder in the DSM-5. Craving is a core phenomenon in addiction that can lead to relapse in problem gambling for pathological gamblers. Exposure Therapy (ET) focuses on craving in addiction treatment. ET in Cognitive-Behavioral Therapy (CBT) is based on classical conditioning that addresses the association between contextual cues and the craving response. ET helps the patient to reduce craving when faced with cues triggering craving. ET includes in vivo exposure and imaginal exposure. The literature recommends being as close as possible to the context of addiction to facilitate the extinction of craving but in vivo ET is complicated to perform. For GD, in outpatient consultation, bringing a patient to a casino presents obstacles (e.g., time, human and financial cost, agreement with casino for therapy).
The study will be to assess the effectiveness of Virtual Reality Exposure Therapy (VRET) in a virtual gambling environment. Various trials show that VRET is no more or less effective than classical ET in CBT but has other advantages for motivation to treatment. This research aims to compare efficacy between CBT with VRET and CBT with imaginal exposure for treatment of GD in a multicenter, randomized, controlled, non-inferiority clinical trial.
Main aim:
Show, within patients seeking care for GD, that VRET integrated with CBT is non-inferior to imaginal ET integrated with CBT on GD symptom reduction at the end of 12 treatment sessions.
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT with VRET | Experimental |
| |
| CBT with imaginal ET | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive-behavioral therapy for gambling disorder | Other | 6 sessions of cognitive-behavioral therapy for gambling disorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in South Oaks Gambling Screen (SOGS) between baseline and end of treatment (12 sessions, 6 months) | The SOGS is a 20-item instrument used to screen for pathological gambling. The SOGS is scored by summing the number of items endorsed out of 20 and a cut score of 5 or more indicates a probable pathological gambling. The score ranges from 0 to 20. | at the end of treatment (an average of 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in South Oaks Gambling Screen (SOGS) between baseline and follow-up at 3, 6 and 12 months after the end of treatment | The SOGS is a 20-item instrument used to screen for pathological gambling. The SOGS is scored by summing the number of items endorsed out of 20 and a cut score of 5 or more indicates a probable pathological gambling. The score ranges from 0 to 20. | at baseline, and through study completion, an average of 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre TAQUET, PhD | Contact | 0320445838 | +33 | pierre.taquet@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre TAQUET, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens-Picardie | Not yet recruiting | Amiens | France |
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| imaginal exposure therapy focus on gambling cues | Other | 6 sessions of imaginal exposure therapy focus on gambling cues |
|
| virtual reality exposure therapy focus on gambling cues | Other | 6 sessions of virtual reality exposure therapy focus on gambling cues |
|
| Change in gambling disorder symptoms between baseline, end of treatment and follow-up assessed by the following criteria: number of DSM-5 criteria for GD | Nine criteria for gambling disorder are described in DSM-5. The endorsement of 4-5 criteria means the presence of a mild gambling disorder, 6-7 criteria a moderate gambling disorder and 8-9 criteria a severe gambling disorder. The score ranges from 0 to 9 criteria. | at baseline, and through study completion, an average of 18 months |
| Change in gambling disorder symptoms between baseline, end of treatment and follow-up assessed by the following criteria: Problem Gambling Severity Index (PGSI) | The PGSI consists of nine items to assess level of risk for problem gambling. Cut-off scores are 1-2 for low-risk gamblers, 3-7 for moderate-risk gamblers and 8 or more for problem-gamblers. Non-problem gamblers correspond to 0. The score ranges from 0 to 27. | at baseline, and through study completion, an average of 18 months |
| Change in gambling behavior assessed by gambling frequency during the last month | at baseline, and through study completion, an average of 18 months |
| Change in gambling behavior assessed by amount of money spent in gambling during the last month | at baseline, and through study completion, an average of 18 months |
| Change in gambling behavior assessed by time spent gambling during the last month | at baseline, and through study completion, an average of 18 months |
| Change in frequency subscale of gambling Craving Experience Questionnaire (g-CEQ) | The frequency subscale of gambling Craving Experience Questionnaire assesses the frequency of craving for gambling during the last week. This questionnaire consists of nine items. A high score means a high frequency of craving during the last week. The score ranges from 0 to 90. | at baseline, and through study completion, an average of 18 months |
| Change in craving reactivity to gambling cues | at baseline, and through study completion, an average of 18 months |
| Number of craving episodes using daily craving assessed by participants | up to 6 months during the treatment |
| Cumulative duration of craving episodes using daily craving assessed by participants | up to 6 months during the treatment |
| Change in gambling-related cognitions assessed by Gambling-Related Cognitions Scale (GRCS) | The French version of the Gambling-Related Cognitions Scale consists of 23 items to assess various cognitions related to gambling. A high score means that gambling-related cognitions are typical cognitions of problem gamblers. The score ranges from 23 to 161. | at baseline, and through study completion, an average of 18 months |
| Change in depressive symptoms assessed by Beck Depression Inventory short-form (BDI-SF) | Beck Depression Inventory short-form consists of 13 items to assess depressive symptoms. A high score means a high level of depressive symptoms. The score ranges from 0 to 39. | at baseline, and through study completion, an average of 18 months |
| Change in anxiety symptoms assessed by State-Trait Anxiety Inventory (STAI) | State-Trait Anxiety Inventory consists of 20 items to assess state-anxiety and 20 items to assess trait-anxiety. A high score means a high level of anxiety symptoms. The score ranges from 20 to 80 both for state-anxiety and trait-anxiety. | at baseline, and through study completion, an average of 18 months |
| Rate of patients who attended the 12 sessions (6 months) | Quality of the two therapeutic strategies | up to 6 months during the treatment |
| CH Boulogne sur mer CSAPA | Not yet recruiting | Boulogne-sur-Mer | France |
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| CHU de Caen | Not yet recruiting | Caen | France |
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| Hôpital Fontan, CHU lille | Not yet recruiting | Lille | 59000 | France |
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| Assoriation Cédragir Lomme CSAPA | Not yet recruiting | Lomme | France |
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| CH de l'arrondissement de Montreuil / CSAPA | Not yet recruiting | Montreuil-sur-Mer | France |
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| CHU Rouen | Not yet recruiting | Rouen | France |
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| CH de Saint Amand les Eaux | Not yet recruiting | Saint-Amand-les-Eaux | France |
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| CH Seclin Carvin CSAPA | Recruiting | Seclin | France |
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| Association GREID ValenciennesCSAPA | Not yet recruiting | Valenciennes | France |
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| ID | Term |
|---|---|
| D005715 | Gambling |
| ID | Term |
|---|---|
| D012309 | Risk-Taking |
| D001519 | Behavior |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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